Clinical Research Nurse Practitioner

7 days ago


Santa Barbara, California, United States Sansum Diabetes Research Institute Full time
Position Overview

Salary: $63.85 per hour

KEY RESPONSIBILITIES

Under the mentorship of the Principal Investigator and the Director of Clinical Research Operations, the incumbent will function as a Nurse Practitioner and Sub-Investigator on various clinical research projects that necessitate the oversight of a medical professional. Flexibility in work hours is essential to accommodate project demands, including potential evening and weekend shifts.

This role encompasses the following specific responsibilities:

  1. Collaborate with the Principal Investigator or other Sub/Co-Investigators on clinical research trials.
  2. Assist in the execution and implementation of clinical study protocols.
  3. Ensure adherence to protocol requirements as dictated by the sponsor, Standard Operating Procedures (SOPs), local and/or central Institutional Review Boards (IRB), and the U.S. Food and Drug Administration (FDA).
  4. Engage with sponsors to clarify permissible trial activities for Nurse Practitioners.
  5. Conduct research activities such as physical assessments, reviewing and validating source documents and case report forms (CRF), including but not limited to medical history forms.
  6. Be available on-call for clinical research subjects in coordination with the Principal Investigator.
  7. Provide essential Family Nurse Practitioner (FNP) care to research study participants, including:
    1. Performing medical assessments alongside registered nurses, including vital signs, imaging studies, electrocardiograms, IV line insertion, and blood draws.
    2. Administering investigational medications and conducting patient evaluations during clinic visits to monitor for side effects, notifying the Principal Investigator as necessary.
    3. Educating study participants to ensure comprehension of medication dosages, administration, and disease management.
  8. Address any medical inquiries raised by the sponsor, IRB, or FDA concerning specific clinical trials.
  9. Engage in ongoing education regarding the roles and responsibilities of a research Sub-Investigator and complete any necessary training mandated by the sponsor, IRB, or FDA.
  10. Perform additional duties as assigned.

SUPERVISORY ROLE

This position does not entail supervisory responsibilities; however, the Sub-Investigator may guide research staff in medical decision-making during clinical trial activities.

QUALIFICATIONS

The candidate must demonstrate the ability to perform each essential duty effectively. Training will be provided as needed, with specific support available for areas requiring refreshment. The qualifications listed below represent the knowledge, skills, and abilities required:

  • Knowledge and skills pertinent to licensed Nurse Practitioners in California.
  • Fundamental understanding of accepted clinical research practices, including universal precautions, human subjects research protocols, and HIPAA regulations.
  • Ability to work autonomously with meticulous attention to detail.
  • Strong organizational and multi-tasking capabilities.
  • Exceptional oral and written communication skills.
  • Ability to establish rapport and communicate effectively with individuals from diverse cultural and educational backgrounds.
  • Capacity to prioritize and delegate tasks while fully engaging in clinical research trials.

EDUCATION AND EXPERIENCE

  • Licensed Nurse Practitioner in California.
  • Interest and experience in diabetes management, including education and care.
  • Certification as a Diabetes Educator or Board Certification in Advanced Diabetes Management is preferred.
  • Experience in clinical research environments is advantageous.

LANGUAGE PROFICIENCY

Proficiency in reading, writing, and speaking English is essential. The ability to interpret documents such as safety protocols, SOPs, and procedures is critical, along with a comprehension of scientific terminology.

PHYSICAL REQUIREMENTS

The physical demands outlined here are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made for individuals with disabilities:

The incumbent must regularly sit, talk, hear, and navigate stairs. Frequent use of hands for handling equipment, paperwork, or files is necessary. The role requires standing, walking, and reaching with hands and arms. The employee may occasionally lift and/or move up to 10-20 pounds. Specific vision capabilities required include close vision.

This position necessitates manual dexterity, skill, and adequate vision to accurately record data, as well as sufficient hearing and verbal communication skills to interact with study participants. Prolonged standing and light lifting may be required.

The incumbent must maintain overall health to consistently report for work and fulfill a standard workday with appropriate breaks.

WORK ENVIRONMENT

The work environment is primarily an office setting with adjacent clinical facilities and laboratory spaces located on different floors. Mobility within these areas may be necessary to perform job functions. Reasonable accommodations may be made for individuals with disabilities. The noise level is typically moderate, with fluorescent artificial lighting illuminating the workspace.

This position involves exposure to biohazardous materials and communicable diseases, necessitating adherence to universal precautions at all times, along with other conditions typical of a medical clinic and research facility.

This job description aims to outline the general requirements for job performance. It is not an exhaustive list of duties, responsibilities, or qualifications, and additional tasks may be assigned as needed.



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